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Bio-Rad Receives 510(k) Clearance for Congenital Disease IgM Assay

NEW YORK (360Dx) – Bio-Rad Laboratories said Thursday that the US Food and Drug Administration has cleared its BioPlex 2200 ToRC IgM Assay, an automated and multiplexed panel for the detection of IgM class antibodies to Toxoplasma gondii, rubella, and cytomegalovirus (CMV).

Toxoplasma gondii, rubella, and CMV are pathogens commonly associated with congenital diseases and therefore are tested during the first trimester of pregnancy.

John Hertia, the president of Bio-Rad's Clinical Diagnostics Group, said in a statement that "the BioPlex 2200 ToRC IgM panel complements the existing BioPlex 2200 ToRC IgG Assay and provides laboratories with a full serological profile for these markers in an efficient multiplex format."

The IgM assay runs on the BioPlex 2200 System, a fully automated platform that enables clinical laboratories to rapidly multiplex multiple individual tests that are traditionally processed separately, conserving patient sample volume, and simplifying workflow, Bio-Rad said.